510(k) · Cleared
ClearedPrecision Plus Tuna Office System; Presision Tuna Office System; Provu Tuna System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 28, 2002 as substantially equivalent to K014224 (Vidamed, Inc., 2002) and 2 other predicates after an 86-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Aug 28, 2002
- Review
- 86 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K951245 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK951245 Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable…Vidamed, Inc. · 1995
- 2 generations backK960918 Vidamed Tuna (Transurethral Needle Ablation) SystemVidamed, Inc. · 1996
- 1 generation backK965061 Vidamed Modedl 7600 RF GeneratorVidamed, Inc. · 1997
- This deviceK021804 Precision Plus Tuna Office System; Presision Tuna Office System…Medtronic Vascular · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951245 | Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable Electrosurgical… | Vidamed, Inc. | 1995 | — |
| −2 | K960918 | Vidamed Tuna (Transurethral Needle Ablation) System | Vidamed, Inc. | 1996 | — |
| −1 | K965061 | Vidamed Modedl 7600 RF Generator | Vidamed, Inc. | 1997 | — |
| 0 (this device) | K021804 | Precision Plus Tuna Office System; Presision Tuna Office System; Provu Tuna… | Medtronic Vascular | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K014224 | Precision Plus Tuna Office SystemSummary page 2…product family with the added contraindication is being compared to the following Marketed Device: Precision Plus TUNA Office System (510(k): K014224) Precision TUNA Office System (510(k): K002583) PROVu TUNA System (510(k): K965061)… | 2002 |
| * | K002583 | Tuna (Trans Urethra Needle) Office SystemSummary page 2…PROVu TUNA System (510(k): K965061); was deemed substantially equivalent on January 28,1997. Precision TUNA Office System (5 lo&): K002583); was deemed substantially equivalent on February 13,200 1. Precision Plus TUNA Office System (5 lO(k… | 2001 |
| * | K965061 | Vidamed Modedl 7600 RF GeneratorSummary page 1…vices and Accessories NAME OF PREDICATE OR LEGALLY MARKETED DEVICE Precision Plus TUNA Office System, KO14224 Precision TUNA Office System, KO02583 PROVu TUNA System, K965061 DESCRIPTION OF DEVICE Each system of the TUNA system product family consists of an RF generator, sterile single-use cartridge,… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K014224.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The TUNA System Product Family, including Precision Plus TUNA Office System, Precision TUNA Office System, and PROVu TUNA System is indicated for use in the treatment of
symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in
men over the age of 50 with prostate sizes between 20 and 50 cc.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021804 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021804: Precision Plus Tuna Office System; Presision Tuna Office System; Provu Tuna System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021804
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026